VERSION 3 OPERATING SYSTEM SOFTWARE— 510(k) K935670

Name: FDA 510(k) clearance K935670
Creator: U.S. Food and Drug Administration
Published: 1994-03-30

Substantially Equivalent

Hitachi Medical Systems America, Inc.

FDA 510(k) clearance K935670 for VERSION 3 OPERATING SYSTEM SOFTWARE, Substantially Equivalent on 1994-03-30. Applicant: Hitachi Medical Systems America, Inc.. Device class: 2.

Clearance details

Applicant: Hitachi Medical Systems America, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 1993-11-26
Decision date: 1994-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twinsburg, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.